HANDY SOLUTIONS KIDZ CREST SPARKLE FUN- sodium fluoride paste, dentifrice
Navajo Manufacturing Company Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Handy Solutions Kidz Crest Toothpaste

Active ingredient

Sodium fluoride 0.243% (0.15% w/v fluoride ion)

Purpose

Anticavity toothpaste

Uses

helps protect against cavities

Warnings

Keep out of reach of children under 6 yrs. of age.

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

adults and children 2 yrs. and older: brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist
do not swallow
to minimize swallowing use a pea-sized amount in children under 6
supervise children's brushing until good habits are established
children under 2 years : ask a dentist

Inactive Ingredients

sorbitol, water, hydrated silica, sodium lauryl sulfate, trisodium phosphate, sodium phosphate, cellulose gum, flavor, sodium saccharin, carbomer, mica, titanium dioxide, blue 1

Questions or comments?

1-800-492-7378

Handy Solutions Kidz Crest Toothpaste 53.87g (67751-094-01)

Kids Toothpaste Toothbrush Kit

HANDY SOLUTIONS KIDZ CREST SPARKLE FUN
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:67751-094
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.243 mg in 100 g

Ingredient Name	Strength
Inactive Ingredients
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM PHOSPHATE (UNII: SE337SVY37)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
MICA (UNII: V8A1AW0880)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:67751-094-01	1 in 1 BLISTER PACK	08/21/2013	01/01/2021
1		53.87 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	08/21/2013	01/01/2021

Labeler - Navajo Manufacturing Company Inc. (091917799)

Name	Address	ID/FEI	Business Operations
Establishment
THE PROCTER & GAMBLE MANUFACTURING COMPANY		005279245	manufacture(67751-094)

Name	Address	ID/FEI	Business Operations
Establishment
Navajo Manufacturing Company Inc		136941411	repack(67751-094) , relabel(67751-094)

Revised: 12/2020

Document Id: b5809910-dd99-0717-e053-2995a90ab059

Set id: 7be6b9bb-c78a-475c-94fc-08b8417e73b0

Version: 5

Effective Time: 20201202

Navajo Manufacturing Company Inc.